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Tuesday, July 27, 2010

Sterilization Validation and Routine Operation Handbook: Radiation

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details
all steps from prevalidation planning to final report and ongoing
monitoring and control. Sterilization Validation & Routine Operation
Handbook: Radiation provides a framework for the validation and routine
operation of an irradiation sterilization process. The guidance
presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of
health care product-Requirements for validation and routine
control-Radiation sterilization and the newly published AAMI
substantiation of 25 kGy using VDmax procedure. The author discusses
methods to aid in comprehending the requirements in these standards. She
also provides practical procedures for the validation and routine
monitoring and control of specific
gamma and electron beam radiation sterilization processes.Background
chapters provide needed information on radiation sterilization
technologies, sterilization microbiology, validation approaches and
working with a radiation sterilization contractor. Much of the
information in this new book is presented in convenient tables and
charts, with diagrams and other schematics that simply illustrate
appropriate validation methodologies. Sterilization Validation &
Routine Operation Handbook, Radiation brings together in one resource
information scattered throughout many documents and will be useful to
all those involved in the sterilization of medical Justify Fullmaterials, drugs and devices.


Paediatric Drug Handling (ULLA Postgraduate Pharmacy Series)

volume in the "ULLA Series" is an introductory textbook on paediatric
drug handling. Written for new pharmaceutical scientists, this book aims
to give a background of paediatric pharmacy. Its scope is to give a
comprehensive introduction to children's medication in terms of dosing in practice and paediatric pharmaceutics, physiological and drug disposition differences, clinical
pharmacology and pharmacogenomics. Paediatric regulations around the
world as well as drug licensing and clinical trials, compliance, safety
and pharmacovigilance issues will also be developed.

Good Laboratory Practice: OECD Principles And Guidelines for Compliance Monitoring

publication unites all of the OECD documents related to Good Laboratory
Practice and compliance monitoring, and, in the Annex, reproduces the
three OECD Council Decisions related to the Mutual Acceptance of Data in
the Assessment of Chemicals. It includes the international standards
for quality of non-clinical environmental, health and safety
data on chemicals and chemical products in a regulatory context—the
OECD Principles of Good Laboratory Practice—and supporting Consensus and
Advisory Documents on their interpretation and application. The OECD
guidance documents for governments
on monitoring compliance with the Good Laboratory Practice Principles
are also included. This publication thus presents the state of the art
on Good Laboratory Practice and compliance monitoring.

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

With over twenty different official regulatory statements
worldwide on Good Manufacturing Practice (GMP) for pharmaceutical,
drug, or medicinal products, two stand out as being the most influential
and most frequently referenced. Bridging the gap between U.S.
regulations and European Good Manufacturing Practice guidelines, Good
Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans
the most important substance from the U.S. Current Good Manufacturing
Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to
Good Manufacturing Practice for Medicinal Products for Human and
Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of
experience in technical management, production, quality assurance, and
distribution within the pharmaceutical industry, offering a hands-on
guide to better understand and implement optimal pharmaceutical
practices. This book also compares the principle requirements of GMP,
and explores the reasoning behind these requirements and ways to comply
with them. Relevant topics include personnel, documentation, premises
and equipment, production, quality control, self-inspection, recalls,
and more. This is an essential guidebook for those who wish to expand
their pharmaceutical business in any international capacity.


Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

of the biggest computer validation challenges facing pharmaceutical
manufacturers is the large corporate system. This book provides
practical information and advice on good IT practice and validation
principles. Written by experts, it includes case studies on EDMSs, EAM
systems, LIMSs, and MRP II systems. Topics include paper- and peopleless
plants, GxP compliance, integrating manufacturing systems, electronic
signatures, validating asset management systems,
enterprise/manufacturing planning systems, lab information management
systems, and Local & Wide Area Networks, compliance for IT
Infrastructure, IT system maintenance and support, and auditing
suppliers, software Integrators, and hardware manufacturers.


Validated Cleaning Technologies for Pharmaceutical Manufacturing

by an expert for those who must design validatable cleaning processes
and then validate those processes, this book discusses interdependent
topics from various technical areas and disciplines. It shows how each
piece of the cleaning process fits into the validation program, making
it more defensible in both internal quality audits and external
regulatory audits. Designed for use in the overall validation program,
the book demonstrates how to build a comprehensive program, and includes
discussion and examples of cleaning systems, regulatory requirements,
and special topics and issues. It provides an FDA cleaning validation
guidance document and a comprehensive glossary.


21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

the FDA regulated environment, it is not acceptable for programmers or
their managers to deviate from standardized methodologies. Given the
type of software commonly found in FDA regulated operations, the
criticality and complexity of computer systems, the evolving regulatory
climate, and the current industry best practices, validating computer
systems can be problematic. Covering regulatory requirements stipulated
by FDA and GAMP guidelines, 21 CFR 11: Complete Guide to International
Computer Validation Compliance for the Pharmaceutical Industry
delineates the organization, planning, verification, and documentation
activities and procedural controls required for compliance. Whether you
need to validate computer systems for pharmaceutical cosmetic, food, or
medical devise applications, this book is indispensable. Discussing the
regulatory requirements that are the foundation for any project, the
book introduces a model that can be used to determine the Part 11
requirements for consideration during implementation. The book
establishes a top-down approach to the integration of computer systems
validation strategies in support of a computer systems validation
project. It focuses on practical issues in computer systems
implementation and operational life project management, including
relevant activities to comply with Part 11, validation planning, and
scheduling. The book reviews documentation in relation to CSV and
procedural controls in regulated operations. The book shows how to
enable compliance with computer systems validation requirements while
highlighting and integrating Part 11 requirements into the entire
computer validation program. The author places regulatory compliance
within the context of quality assurance and emphasizes the importance of
integrating validation into the system lifecycle using a structured
top-down approach. This systematic approach helps you efficiently
develop compliant software and maintenance its compliance.


Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance

Master Validation Plan provides a roadmap to management for on-time
start-up of facility operations, and validation of existing facilities,
in compliance with GMP requirements. The lack of a comprehensive Master
Validation Plan and well-documented validation procedures is the main
reason that new drug, medical device, medical equipment, and related
product applications are rejected by the FDA. In fact, only about 2% of
the applications submitted by foreign pharmaceutical companies are
approved each year. This thorough guide provides the needed solutions
and guidance for both foreign and U.S. companies to achieve FDA
compliance and authorization to market their products in the United
States. Pharmaceutical Master Validation Plan: The Ultimate Guide to
FDA, GMP, and GLP Compliance will allow you to more easily achieve
satisfactory inspections, new medical product approval, minimize
non-conformance, reduce rework and rejected lots, and avoid recall lots
by developing and managing a Master Validation Plan. The accompanying CD
allows users to input the template plan into their computers and tailor
it to incorporate additional regulatory requirements specific to
individual companies worldwide and print the required documents.
Together, the book and CD contain everything required to develop and
execute a successful Master Validation Plan based on FDA guidelines for
the pharmaceutical industry, and allows the templates to be extended to
diagnostic products, medical device, medical equipment, and biotech
industry products.


Laboratory Auditing For Quality and Regulatory Compliance

current tools, techniques, and approaches for the evaluation of
laboratory operations, this reference reviews the latest regulatory
standards and auditing practices to test laboratory safety, quality, and


Standard Operating Procedures: A Step by Step Guide for Achieving
Compliance in the Pharmaceutical, Medical Device, and Biotech

Standard Operating Procedures: A Step by Step Guide for Achieving
Compliance in the Pharmaceutical, Medical Device, and Biotech
Industries, Second Edition

every critical element of validation for any pharmaceutical,
diagnostic, medical device or equipment, and biotech product, this
Second Edition guides readers through each step in the correct execution
of validating processes required for non-aseptic and aseptic
pharmaceutical production. With 14 exclusive environmental performance
evaluations, it features 64 new protocols on topics such as sterility
assurance, media fill guidelines, and environmental control.


Testing Computers Systems for FDA/MHRA Compliance

is no substitute for extensive testing when it comes to IT systems.
Recognition that problems are easier and cheaper to fix before the
system is in use (rather than after), has turned testing into a
cost-effective tool. However, when developing computer systems for
pharmaceuticals manufacturing, testing to meet regulatory requirements
adds an additional layer of complexity. Testing Computers Systems for
FDA/MHRA Compliance focuses on software module, software integration,
hardware, and system acceptance testing. Reflecting the renewed emphasis
of the FDA and other global regulatory agencies towards systematic
inspections and risk-based validation with an underlying scientific
rationale, this guide focuses on current best practices in computer
systems testing in the regulatory environment. David Stokes demonstrates
how the principles detailed in the GAMP 4 Guide can be used to define a
pragmatic approach to testing. He includes techniques for testing large
Internet-based systems for compliance with the stringent requirements
of regulations such as 21CFR Part 11, and clarifies the relationship and
responsibilities of the system "user" and "supplier". The author also
delineates where testing starts in the project lifecycle, who performs
what testing, where the lines of responsibility start and end, and the
differences in the terminology used in the healthcare and general IT
sectors. A checklist of questions to be used when developing System Test
Specification(s), and templates for documenting typical system test
results, round out the features that make this book a practical guide
for all those involved in the development and implementation of IT
systems for the pharmaceutical and related healthcare manufacturing
industries. Senior managers, team project leaders, project team members,
and industry trainees, will all benefit from this clear and practical


Regulatory Focus - September 2008

Where is our profession headed?

A Seat at the Table:Regulatory in Corporate Health care

Managing Global Business Risk:The New Role of Regulatory Leaders

Mergers, Acquisitions and Operational Risk

The Regulatory Professional:A Jack of All Trades

Regulating Nanotechnology in the US & EU

Rapid Microbiological Methods in the Pharmaceutical Industry

recent years there has been increased interest in the possibility of
rapid microbiological methods offering enhanced potential error
detection capabilities. However, these methods raise a number of
questions, such as how to validate new methods, will they be accepted by
the pharmacopoeias, and, most importantly, how will the regulators
respond? Rapid Microbiological Methods in the Pharmaceutical Industry
answers these questions and more. Martin Easter and his panel of
experts: § Describe the range of rapid microbiological methods and their
applications, including practical tips, and their status regarding
validation, established use, and regulatory acceptance § Explore the
origins of current methods and the current issues facing the
requirements of microbiology and its associated test methods § Delineate
the challenges involved in seeking better and more pragmatic methods
for the assessment of microbial hazards and risks to ensure product and
consumer safety The book assists you in applying an effective system to
assess the real microbiological hazards and, hence, quantify realistic
risks. Additionally, it provides monitoring methods that will deliver
meaningful, useful data for effective decision making in manufacturing,
quality assurance, and product safety. The expert and authoritative
information in Rapid Microbiological Methods in the Pharmaceutical
Industry will help you find better solutions to ensuring the
microbiological safety of pharmaceutical products.


Quality (Pharmaceutical Engineering Series), Volume 2

Pharmaceutical Engineering Series is a comprehensive reference for the
pharmaceutical professional covering all aspects from quality,
documentation and validation through manufacturing processes to facility
design and management. In 'Quality', Dr Kate McCormick provides the
reader with comprehensive coverage of this vital subject, including the
quality life cycle, management and cost of quality, GMP, auditing and
inspections. This book with the others in the series will become a
unique source of reference and educational material for the readership.

Case studies and examples make the book of direct practical relevance to the professional in the pharmaceutical industry

Find the answers you are looking for quickly and easily with clear indexing and referencing

Reference to international standards and practice mean this book will be useful wherever you are working.


Validation of Pharmaceutical Processes, 3rd Edition

revised and updated to reflect the significant advances in
pharmaceutical production and regulatory expectations, this third
edition of Validation of Pharmaceutical Processes examines and
blueprints every step of the validation process needed to remain
compliant and competitive. The many chapters added to the prior
compilation examine validation and six sigma system design; the
preparation of aseptic and non-aseptic pharmaceutical products; active
pharmaceutical ingredient and biotechnology processes, computerized
systems; qualification and cleaning of equipment; analytical methods,
calibration and certification. As the industry's leading source for
validation of sterile pharmaceutical processes for more than 10 years,
this greatly expanded is a comprehensive analysis of all of the
fundamental elements of this arena with practical solutions for every
pharmaceutical and bio-pharmaceutical production process. Presenting
theoretical knowledge and applied practical considerations, this title ·
provides an in-depth discussion of recent advances in sterilization ·
identifies obstacles that may be encountered at any stage of the
validation program, and suggests the newest and most advanced solutions ·
explores distinctive and specific process steps, and identifies
critical process control points to reach acceptable results · blends the
use of theoretical knowledge with recent technological advancements to
achieve applied practical solutions

Combination Products: Regulatory Challenges and Successful Product Development

field of combination product development (products born of the
integration of medical devices, biologics, and drugs) is so new that,
while literature abounds on each part individually, there are very few
publications, including FDA documents, available concerning the unique
challenges posed by this nascent but fast-growing area. Providing the
first in-depth look at this breakthrough field, Combination Products
includes practical guidelines and a detailed step-by-step process for
the development of these novel technologies. It addresses the technical,
scientific, regulatory, and quality issues that arise when combining
drugs, biologics, and medical devices into a single product. It takes a
practical, readily applicable approach to discussing the challenges,
victories, and pitfalls associated with merging technologies and systems
and how to implement these products into the market successfully and in
a timely manner. Specifically, this text explores the process from
start to finish, establishing a workable design and development plan
complete with relevant definitions. It reviews FDA and other regulatory
expectations and covers resource requirements, manufacturing pitfalls,
post-launch compliance requirements, and agency audits and challenges.
Drawing on the experience and expertise of two leaders in their
respective fields, Combination Products boasts the credentials of
Dr. Smita Gopalaswamy, a 20 year veteran of technical consulting
responsibilities in medical device, biologics, and pharmaceutical
industries as well as combination products, along with the support of
Dr. Venky Gopalaswamy, an expert in business improvement methodologies
such as six sigma, lean, and change management, to provide a
comprehensive assessment of the field and an efficient and effective
approach to the creation and implementation of combination products.


Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition

This Second Edition
is an essential guide to preparing for FDA pre-approval
inspections—taking into account current trends in FDA expectations and
inspection activities, such as the GMPs of the 21st Century,
quality systems-based approach to inspections, risk-based inspections,
quality by design, process analytical technology, design space, etc.
The goal of this book is to help organizations gain rapid regulatory


Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

the recently passed 45 CFR, and the parallel CFR 21 Part 11 and HIPAA
regulations 160, 162, and 164, this book provides guidance for
purchasing, installing, validating, and managing commercial
off-the-shelf software data for collection and retention. Addressing the
interface between these regulations and how to be in compliance with
them, the authors cover audit trails, validation, documentation,
training, and how to establish and maintain security and accountability.
They discuss what the regulations mean in terms of industry standard,
explain the audit function for facilities that are subject to the newer
HIPAA regulations, and present the standards for documentation.

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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

book covers the regulatory process for getting pharmaceuticals,
biologics, and medical devices approved. It examines the pertinent
aspects of the Federal Food, Drug and Cosmetic Act as it applies to
human drug and device development, research, manufacturing, and
marketing. Topics include: the drug approval process, Current Good
Manufacturing Practices, Good Clinical Practices, Quality System
Compliance and the corresponding documentation requirements, and FDA
inspection processes and enforcement options. Although many references
exist on this subject, this one is written in a general prose style that
makes it useful to both students and professionals.

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Clinical Research Coordinator Handbook: GCP Tools and Techniques, Second Edition

revised edition of a bestseller provides a logical, step-by-step guide
to testing new drugs and treatment modalities in compliance with the
latest FDA regulations. Using current forms, ICH GCP information, FDA
regulations, and other references, it shows readers how to manage a clinical research
study effectively and efficiently. Chapters include: Overview of
Clinical Research, FDA Regulations and Good Clinical Practice
Guidelines, The Study: Planning Stages and Commencement, Interactions
with the Sponsor, Interactions Within the Institution; The Role of the
Study Subjects, Data Management: Adverse Events, Investigational Agent
Management, and Inspection of Clinical Research Sites.

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